510(k) Report

510(k) · Cleared

Cleared

Burron Microcath Intra. Cath. Placementt

K801941510(k) TraditionalCleared Aug 27, 198014-day reviewClass II21 CFR 880.5200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Burron Medical Products, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Aug 27, 1980 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 72 later devices descend from it.

Decided
Aug 27, 1980
Review
14 days
Class
Class II
Product code
FOZ
Recalls
None
Predicates
0

72 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1995: 1 descendant cleared2002: 3 descendants cleared2006: 1 descendant cleared2012: 6 descendants cleared2011: 3 descendants cleared2022: 7 descendants cleared2017: 4 descendants cleared2023: 1 descendant cleared2008: 2 descendants cleared2020: 5 descendants cleared2003: 1 descendant cleared2005: 1 descendant cleared2009: 3 descendants cleared2010: 1 descendant cleared2019: 2 descendants cleared2025: 5 descendants cleared2026: 3 descendants cleared2007: 1 descendant cleared2014: 5 descendants cleared2015: 3 descendants cleared2013: 2 descendants cleared2021: 3 descendants cleared2018: 1 descendant cleared2016: 5 descendants cleared2024: 2 descendants cleared19801990200020102020
  1. This deviceK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
  2. Descendant · cites it directly · 70 of its ownK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 55 of its ownK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 26 of its ownK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
  5. Descendant · 3 generations on · 25 of its ownK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
  6. Descendant · 4 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

1995: 11999: 12002: 32003: 12005: 12006: 12007: 12008: 22009: 32010: 12011: 32012: 62013: 22014: 52015: 32016: 52017: 42018: 12019: 22020: 52021: 32022: 72023: 12024: 22025: 52026: 3
1995high 7 (2022) · low 0 (1996)2026

Most influential descendants

Showing 5 of 72 · See all
  • K982805Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · cites it directly70descendants
  • K020785Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · 2 generations on55descendants
  • K021094Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · 2 generations on26descendants
  • K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · 3 generations on25descendants
  • K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 4 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K801941Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc.1980—
+1K982805Introcan Safety IV CatheterB.Braun Medical, Inc.19991
+2K020785Introcan Safety IV CatheterB.Braun Medical, Inc.20022
+2K021094Introcan Safety IV CatheterB.Braun Medical, Inc.20021
+3K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc.2011—
+4K121073Powerglide Midline CatheterC.R. Bard, Inc.20121

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199510
199910
200230
200310
200510
200610
200710
200820
200930
201010
201130
201260
201320
201450
201530
201650
201740
201810
201920
202050
202130
202270
202310
202420
202550
202630
FIG. 1 — Lineage of K801941, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FOZ device

  1. #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (72)

See all 72

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982805Introcan Safety IV CatheterB.Braun Medical, Inc.199970
K946170Comfort-Q Subcutaneous Injection SetsB. Braun of America, Inc.19950

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K982805 (B.Braun Medical, Inc., 1999) has gone furthest, with 70 descendants of its own.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FOZ

11in 2025

2007: 62008: 92009: 92010: 32011: 62012: 132013: 42014: 92015: 102016: 92017: 92018: 12019: 82020: 102021: 42022: 82023: 92024: 62025: 112026 (partial year): 7
2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007: 159 days median2008: 103 days median2009: 30 days median2010: 28 days median2011: 132 days median2012: 122 days median2013: 104 days median2014: 99 days median2015: 107 days median2016: 63 days median2017: 51 days median2019: 140 days median2020: 191 days median2021: 242 days median2022: 183 days median2023: 129 days median2024: 190 days median2025: 91 days median2026 (partial year): 203 days median
2007high 242 (2021) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FOZ

4in 2023

2007: 162009: 232010: 1152013: 22014: 42016: 3, 1 Class I2017: 222018: 42019: 32020: 32021: 12022: 4, 2 Class I2023: 4, 2 Class I2026 (partial year): 2
2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007: 3742008: 4222009: 5082010: 3702011: 7862012: 5602013: 6402014: 8152015: 7292016: 9252017: 1,9662018: 3,3052019: 4,3652020: 3,7972021: 4,6742022: 4,1332023: 4,4302024: 4,7722025: 5,110
2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007615916374
200891030422
200993023508
2010328115370
201161320786
2012131220560
201341042640
20149994815
2015101070729
20169633 (1)925
2017951221,966
20181—43,305
2019814034,365
20201019133,797
2021424214,674
202281834 (2)4,133
202391294 (2)4,430
2024619004,772
2025119105,110
202672032—

More from Burron Medical Products, Inc.

41 FDA decisions under this applicant name. See the company

  • K870403Cavafix (R) Central Venous Catheter Kit W/SutureBurron Medical Products, Inc. · 1987
  • K862412IntestoplantBurron Medical Products, Inc. · 1986
  • K861479Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
  • K860126Stimuplex, Nerve StimulatorBurron Medical Products, Inc. · 19864 recalls
  • K851293ImplantofixBurron Medical Products, Inc. · 1986

Recent decisions in FOZ

The FOZ category page

  • K260432Ruby Intravascular CatheterVenocare, Inc. · 2026
  • K260165Unimpregnated Central Venous CatheterSpectrum Vascular · 2026
  • K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026
  • K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026

https://510kreport.com/device/K801941 · printed Nov 6, 2026

Cite this page

510(k) Report. “K801941: Burron Microcath Intra. Cath. Placementt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K801941

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026